Against the back drop of crackdown on 5 civic run blood banks in the city, Maharashtra Food and Drug Administration is planning to inspect other semi government and corporation hospitals to address non-compliance of rules.
Schedule âFâ, Part XII-B and/or XII-C of Drugs & Cosmetics Act, 1940 requires that the blood banks shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. It also mandates to provide and maintain adequate technical staff as specified in the law.
Maharashtra FDA has conducted inspections on 15 civic run blood banks in the past three months in Mumbai. Based on the inspections, it suspended licenses of four municipal blood banks and canceled license of one of them. There are around 60 blood banks in the city.
As per the rules, a 24/7 blood bank is required to have at least three BTOs working in shifts. It is also mandatory that collecting and transfusing of blood and its components, such as plasma, white blood cells etc, be done in the presence of a BTO to avoid fatal mistakes.
Drug inspectors are also now being trained on aspects like bio-safety in blood banks, donor management and good lab practices among others following appeals by the blood banks to the Maharashtra FDA Minister for suggesting the state drug regulator to be reasonable while issuing closure notices after inspecting the city blood bank premises.
This according to the blood banks should be considered keeping in view the difficulties faced by civic-run blood bank hospitals in maintaining adequate blood bank staff for its effective functioning.
There are subjects like blood component preparation, equipment, documentation, internal audit, environment and aspects related to waste management which the FDA officials have to touch upon while inspecting a blood bank premise, according to a senior FDA official. That is why, two such sessions have recently been concluded at Tata Hospital and KEM Hospital in Mumbai.
It was observed during the FDA inspections that blood banks which collect and process less than 2,000 units of blood annually have been suggested to be converted to blood storage centres.